Efficacy of Trigeminal Nerve Stimulation for ADHD

Completed · Not applicable · Has a placebo group

Conditions studied: Attention-Deficit Hyperactivity Disorder

In brief

This study is a large multisite randomized clinical trial to asses the efficacy of external trigeminal nerve stimulation (TNS), a novel, minimal risk, non-invasive neuromodulation treatment, for ADHD in children ages 7-12 years old (N=180). Study hypotheses address potential differences in ADHD symptoms over 4 weeks treatment with active vs. sham TNS in an expanded multi-site investigation; whether resting state fronto-parietal connectivity mediates TNS impact on ADHD symptoms; if changes in fronto-parietal activation, as measured by electroencephalography (EEG), predict TNS-related treatment outcomes; and whether a baseline cognitive profile similarly predicts response to TNS therapy.

Key facts

Study ID

NCT05374187

Run by

University of California, Los Angeles

People needed

218

Starts

2022-09-01

Expected to finish

2026-04-10

Last updated by the study team

2026-05-14

Who can join

Age: 7 and older, up to 12. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• male and female children ages 7 to 12 years with DSM-5 ADHD, any current presentation, as determined by diagnostic interview, Kiddie Schedule for Affective Disorders and Schizophrenia (KSADS), and clinical interview;
• total score >= 24 on baseline ADHD-RS;
• CGI-S score at baseline >= 4;
• no current medication with CNS effects (Participants previously on psychostimulant medication will be required to be not optimally treated and off medication for one week or 5 half-lives for all other medications); stable use of supplements will be permitted;
• parents able and willing to monitor proper use of the stimulation device and complete all required rating scales;
• estimated Full Scale IQ >= 80 based on WASI subtests;
• parent and participant able to complete rating scales and other measures in English;
• able to cooperate during EEG

You may not qualify if…

• impaired functioning to a degree that requires immediate initiation of ADHD medication in the opinion of the parents and/or investigator;
• current diagnosis of autism spectrum disorder or major depression;
• history of lifetime psychosis, mania, or seizure disorder;
• baseline suicidality;
• history of seizure disorder or head injury with loss of consciousness

Where it is running

• University of California, Los Angeles — Los Angeles, California, United States
• Seattle Children's Hospital — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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